Completed

Pioglitazone Add-on for Type 2 Diabetes Mellitus Control

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Study Aim

This study aims to evaluate the effectiveness of Pioglitazone as an add-on treatment for Type 2 Diabetes Mellitus control, specifically observing changes in your HbA1c levels after 24 weeks of use.

What is being tested

Pioglitazone 15mg

+ Pioglitazone 30mg Placebo

+ Metformin≥1000mg

Drug
Who is being recruted

Over 19 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2021
See protocol details

Summary

Principal SponsorBoryung Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 28, 2021

Actual date on which the first participant was enrolled.

This study focuses on individuals who have Type 2 Diabetes and are not adequately managing their condition with Metformin and Dapagliflozin. The research aims to evaluate the effectiveness and safety of adding either Pioglitazone 15mg or Pioglitazone 30mg to their current treatment. The potential outcomes of this study could lead to improved care for those struggling to control their Type 2 Diabetes with current medications. During this study, participants will receive either Pioglitazone 15mg, Pioglitazone 30mg, or a placebo, in addition to their ongoing Metformin and Dapagliflozin treatment. The study will measure changes in HbA1c levels, a common indicator of blood sugar control, after 24 weeks of treatment. This will help determine if adding Pioglitazone to the current treatment plan results in improved blood sugar control.

Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Pioglitazone 15mg or Pioglitazone 30mg Add-on in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin and Dapagliflozin
NCT04885712
Principal SponsorBoryung Pharmaceutical Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

378 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: 1. Those who voluntarily signed the informed consent to participate in this study. 2. Adults aged 19 years or older. 3. Those diagnosed with type 2 diabetes mellitus. 4. Subjects taking constant doses of ≥1000mg of Metformin and 10 mg of Dapagliflozin for more than 8 weeks at Visit 1 (regardless of dosage forms (immediate-release and sustained-release) and single agent or combination drug.) 5. Subjects with 7% ≤ HbA1c ≤ 10.5% at Visit 1 and Visit 2 6. Subjects able to understand the study, comply with study procedures, and attend all scheduled visits. Exclusion Criteria: 1. Uncontrolled hyperglycemia at Visit 1 or Visit 2 (subjects with FPG \> 270 mg/dL as a result of the test conducted by the study institution.) 2. Medication compliance is \<70% or \>120% for each BR3003D, BR3003C, BR3003A-2, and BR3003B-2 during the Run-in period at Visit 2. 3. Patients with other types of diabetes instead of type 2 diabetes (e.g., type 1 diabetes, secondary diabetes, or congenital renal glycosuria). 4. Patients with uncontrolled, severe diabetic complications (e.g., proliferative diabetic retinopathy uncontrolled despite medication and severe diabetic neuropathy) 5. Those who suffered from acute or chronic metabolic acidosis within 3 months as of Visit 1, including lactic acidosis and diabetic ketoacidosis. 6. Those with \> 40 kg/m2 of BMI measured at Visit 1. 7. Those with uncontrolled hypertension at Visit 1 or Visit 2 (SBP \> 180 mmHg or DBP \> 110 mmHg). 8. Those diagnosed with cardiovascular diseases (myocardial infarction, stroke, unstable angina, and transient ischemic attack (TIA)) or undergo revascularization within 3 months as of Visit 1 9. Those with heart failure (NYHA class II\~IV) or who had suffered from heart failure. 10. Those who suffered from gastrointestinal diseases that may affect the absorption, distribution, metabolism, and excretion of investigational products or had underwent surgery; 11. Those who underwent surgery requiring general anesthesia within 4 weeks as of Visit 1 or who are scheduled to receive such surgery within 4 weeks after the study ends 12. Those with a history of malignant tumor within 5 years as of Visit 1 13. Those who have a clinically significant liver disease 14. Those who have a clinically significant renal disease 15. Those with clinically significant hematuria detected at Visit 1 or Visit 2 16. Those with chronic diseases requiring the continued use of systemic steroid or immunosuppressants (oral administration, injection, or inhalation). 17. Patients with pituitary insufficiency or adrenal insufficiency. 18. Those with clinically significant severe infection or trauma based on an investigator's judgement. 19. Patients with AIDS. 20. Patients with acute or chronic diseases that may cause histotoxic hypoxia such as respiratory failure and shock. 21. Those who need treatment due to dehydration caused by persistent diarrhea and vomiting or at a risk of fluid volume depletion. 22. Those who have been administered with the following drugs or expected to require the continued administration during the study period: * Those administered with systemic steroid agents (Prednisolone, \>30 mg/day) within 2 weeks as of Visit 1. * Those being administered with thyroid medications and whose dose has been modified within 6 weeks as of Visit 1 (however, dose reduction is accepted.) * Those being administered with diuretics and whose dose has been modified within 8 weeks as of Visit 1 however, dose reduction is accepted.) * Those who have been administered with antidiabetics other than Metformin and Dapagliflozin within 8 weeks as of Visit 1. * Those who have been administered with obesity drugs (e.g., phentermine, phendimetrazine, diethylpropion, and mazindol) within 12 weeks as of Visit 1. * Those who need to take prohibited concomitant medications stated here during the study period. 23. Those with history of alcohol or drug abuse within 1 year as of Visit 1. 24. Those who had allergic reaction to main ingredients or components of the investigational products. 25. Those who had genetic disorders such as galactose intolerance, Lapp lactose deficiency, or glucose-galactose malabsorption. 26. Females who are pregnant or breastfeeding. 27. Patients planning to become pregnant or of childbearing potential, but not using any recognized contraceptive method 28. Those who are currently participating in other ongoing clinical studies or those who have taken the investigational products from other clinical studies within 12 weeks as of Visit 1 29. Those who are judged unsuitable for the study by a principal investigator or investigators.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg Pioglitazone 30mg placebo

Group II

Experimental
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 30mg Pioglitazone 15mg placebo

Group III

Active Comparator
Metformin≥1000mg Dapagliflozin 10mg Pioglitazone 15mg placebo Pioglitazone 30mg placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Asan Medical Center

Seoul, South KoreaOpen Asan Medical Center in Google Maps
CompletedOne Study Center